MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS WITH RADIAL INDICATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number VSP550EX

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

From staff: after left leg endosaphenous vein harvest by first assistant was complete, small burn (about the size of a teardrop) noted on patients left leg next to vein harvest site.Surgeon made aware, bacitracin ointment applied to burn, and leg wrapped in kerlix and ace wrap as per protocol.

• Brand Name: VIRTUOSAPH PLUS WITH RADIAL INDICATION
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• MDR Report Key: 17904420
• MDR Text Key: 325278025
• Report Number: 17904420
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSP550EX
• Device Catalogue Number: VSP550EX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 78 KG